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RecruitingNCT05303415Updated Jun 8, 2026

Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

An interventional study of Neuromodulation with low-intensity focused ultrasound in Pain, sponsored by Virginia Polytechnic Institute and State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study summary

Study of LIFU on fMRI pain signals. Participants receive low-intensity focused ultrasound (LIFU) and fMRI scans to measure changes in both resting and heat pain signals. Physiology may also be measured. Questionnaires and symptom monitoring will take place. The study takes place over 4 study visits.

Read the detailed description

Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and heat evoked brain signaling using a quantitative sensory testing device. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

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Conditions studied

  • Pain

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03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers, all ethnicities, who understand and speak English.

Exclusion criteria

Exclusion Criteria:

Claustrophobia (scanning environment may be uncomfortable). Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Contraindications to CT: pregnancy Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's) History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor) History of head injury resulting in loss of consciousness for >10 minutes. History of alcohol or drug dependence (through self-report).

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    LIFU, heat evoked fMRI signals

    fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).

    Other: Neuromodulation with low-intensity focused ultrasound

Interventions

  • OtherNeuromodulation with low-intensity focused ultrasound

    Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

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What researchers measure

Primary outcomes

  1. fMRI BOLD Signals

    Changes in fMRI BOLD signal

    Time frame: Participant study duration, approximately 3 weeks.

Secondary outcomes

  1. Changes in self-reported perceived pain

    Change in subject perceived pain rating report on a numerical rating scale (0-10, 0 no pain, 10 worst pain)

    Time frame: Participant study duration, approximately 3 weeks.

Other outcomes

  1. Monitoring changes to physiological measures

    Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.

    Time frame: Participant study duration, approximately 3 weeks.

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Study locations

1 of 1 sites recruiting
  • Fralin Biomedical Research Institute
    Roanoke, Virginia 24016, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05303415
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
Wynn Legon (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Mar 31, 2022
Start date
May 6, 2022
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Jessica W Florig, MPH
Contact
legonlab@vtc.vt.edu
540-526-2261

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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